Empagliflozin/Linagliptin, Oral

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KEY POINTS

• This medicine is taken by mouth to treat type 2 diabetes when diet and exercise have not controlled blood sugar levels. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antidiabetic; SGLT2 inhibitor/DPP-4 inhibitor

Generic and brand names: empagliflozin/linagliptin, oral; Glyxambi

What is this medicine used for?

This is a combination of 2 medicines taken by mouth to treat type 2 diabetes when diet alone has not worked. It should not be used to treat type 1 diabetes or diabetic ketoacidosis. This medicine may be used along with other diabetes medicines.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Angioedema (swelling of your face, tongue or throat, and hives or skin rash)
• Diabetic ketoacidosis
• Gallstones
• Genital yeast infections
• High cholesterol or high triglycerides
• Kidney or liver disease
• Low blood pressure
• Pancreatitis
• Problems with alcohol abuse or if you regularly drink alcohol
• Urinary tract infections or trouble urinating

Tell your healthcare provider if you get sick or injured, or if you are scheduled to have surgery. Also, tell your healthcare provider if you are on a low-sodium diet.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine in the morning. You may take it with or without food.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: strong hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, fast heartbeat, seizures, fainting, coma.

What should I watch out for?

Ketoacidosis (increased ketones in your blood or urine) can happen in people with type 1 diabetes and in people with type 2 diabetes taking this medicine, even if blood sugar is less than 250 mg/dL. Ketoacidosis can be life threatening and may need to be treated in the hospital. Stop taking this medicine, check for ketones in your urine, and call your healthcare provider right away if you have: nausea, vomiting, stomach pain, tiredness, or trouble breathing.

Follow the diet and exercise program prescribed by your healthcare provider.

Test your blood sugar on the schedule your provider recommends and keep track of it. See your provider regularly for an A1c test to check the average of your blood sugar over 2 to 3 months. This average is different from your day to day blood sugar. Keep all appointments for these tests.

Alcohol may affect the way your body responds to this medicine and to food. Do not drink alcohol without your healthcare provider’s approval.

When used alone, this medicine may not cause hypoglycemia (low blood sugar). However, when used with insulin or other diabetes medicines, hypoglycemia can happen and may be serious. Low blood sugar can also happen if you miss or delay meals, drink too much alcohol, take too much medicine, or exercise more than usual. Symptoms of low blood sugar include shaking, anxiety, cold sweats, irritability, fast heartbeat, feeling faint, strong hunger, vision problems, headache, nausea, slurred speech, confusion, unusual mood changes, tingling in the lips or tongue, and weakness. Treat the condition quickly by taking glucose tablets or glucose gel (available in drug stores). Do not use cane sugar or sucrose to relieve these symptoms because this medicine keeps your body from using it quickly. If you don't have glucose with you, eat some honey or drink a glass of orange juice to quickly raise your blood sugar level. If you have low blood sugar often, contact your healthcare provider to find out if you need a dosage adjustment.

Rarely, this medicine may cause pancreatitis. If you have stomach pain that is severe and will not go away, with or without vomiting, or severe back pain, contact your healthcare provider right away.

If you have severe nausea, vomiting, diarrhea, or heavy sweating after you start taking this medicine, contact your healthcare provider right away. If you lose too much fluid or salt from your body, you may get dizzy or faint from low blood pressure. Losing too much fluid while taking this medicine may also lead to severe kidney problems.

This medicine may increase the chance of urinary tract infections, or genital yeast infections. Talk with your healthcare provider about what to do if you get symptoms of an infection.

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert. You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. Wear some form of ID stating (such as a Medic Alert bracelet) that you have diabetes. If you become unconscious, the ID tells emergency healthcare providers that you need special care.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Slow, fast, or irregular heartbeat; unusual tiredness or weakness; severe muscle pain; decreased or increased urination; trouble urinating; pain or burning with urination; severe or sudden stomach or back pain; severe and constant joint pain; severe dizziness; fainting; severe drowsiness; confusion; increased thirst or dry mouth; severe vomiting or diarrhea.

Other: Vaginal itching or discharge (women); penis pain, rash, swelling, itching, or discharge (men); stuffy or runny nose.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• Alcohol
• Aliskiren (Tekturna) and aliskiren/hydrochlorothiazide (Tekturna HCT)
• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), and terazosin
• Androgen hormones such as methyltestosterone (Android, Testred) and testosterone (Androderm, AndroGel, Axiron, Testim)
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antibiotics such as ciprofloxacin (Cipro), isoniazid, levofloxacin (Levaquin), linezolid (Zyvox), moxifloxacin (Avelox), nafcillin, ofloxacin, pentamidine (NebuPent, Pentam), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and tetracycline
• Antidepressants such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), nefazodone, sertraline (Zoloft), trazodone, vilazodone (Viibryd), and vortioxetine (Trintellix)
• Antipsychotic medicines such as chlorpromazine, perphenazine, prochlorperazine (Compro), quetiapine (Seroquel), thioridazine, and trifluoperazine
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), eslicarbazepine (Aptiom), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Aspirin and other salicylates
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, and sotalol (Betapace, Sorine)
• Blood pressure medicines such as hydralazine, methyldopa, minoxidil, and reserpine
• Bosentan (Tracleer)
• Calcium channel blockers such as diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as dabrafenib (Tafinlar), doxorubicin (Doxil), enzalutamide (Xtandi), mitotane (Lysodren), osimertinib (Tagrisso), and vinblastine
• Cholesterol-lowering medicines such as cholestyramine (Prevalite), colesevelam (Welchol), colestipol (Colestid), fenofibrate (Antara, Fenoglide, Lipofen, TriCor, Triglide), and gemfibrozil (Lopid)
• Clonidine (Catapres, Kapvay)
• Cold medicines that contain pseudoephedrine (Sudafed) or phenylephrine (Neo-Synephrine, Sudafed PE)
• Corticosteroids such as cortisone, dexamethasone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Disopyramide (Norpace)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Eplerenone (Inspra)
• HIV medicines such as efavirenz (Sustiva), etravirine (Intelence), nevirapine (Viramune), ritonavir (Norvir), tenofovir (Viread), and tipranavir (Aptivus)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings, and hormones such as estradiol (Climara, Estrace, Estraderm, Vivelle) and estrogens such as Cenestin, Estinyl, Estratab, FemPatch, and Premarin
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Natural remedies such as alfalfa, aloe, aminocaproic acid, arginine, bilberry, bitter melon, dandelion, fenugreek, garlic, ginger, ginseng, gymnema, hawthorn, horsetail, lily of the valley, lysine, marshmallow, milkweed, noni juice, St. John's wort, and stinging nettle
• Octreotide (Sandostatin)
• Other diabetes medicines such as canagliflozin (Invokana), chlorpropamide, dapagliflozin (Farxiga), empagliflozin (Jardiance), glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), insulin, linagliptin (Tradjenta), pioglitazone (Actos), saxagliptin (Onglyza), sitagliptin (Januvia), and tolbutamide
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pegvisomant (Somavert)
• Procarbazine (Matulane)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Psyllium (Take psyllium 2 hours before or 2 hours after you take this medicine.)
• Quinine
• Ranolazine (Ranexa)
• Somatropin (Genotropin, Humatrope, Nutropin, Serostim)
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)
• Teriflunomide (Aubagio)
• Thyroid medicines such as levothyroxine (Levo-T, Levothroid, Levoxyl, Synthroid, Unithroid), liothyronine (Cytomel, Triostat), liotrix (Thyrolar), and thyroid USP (Armour Thyroid, Nature-Throid)

Do not drink large amounts of alcohol while you are taking this medicine. Talk to your healthcare provider about this.

Many medicines may change how well this medicine controls your blood sugar. Tell any healthcare providers who treat you that you are taking this medicine for diabetes.

Many nonprescription products contain sugar, alcohol, or other ingredients that may interfere with this medicine or increase your blood sugar. Check product labels for warnings for diabetics or ask your healthcare provider or pharmacist for advice.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.